CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
REMEDYREPACK INC.

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Cetirizine Hydrochloride Tablets USP, 10 mg, Allergy

ACTIVE INGREDIENTS

Active Ingredients (in each tablet)                                                Purpose

Cetirizine HCl USP 10 mg................................................................Antihistimine

PURPOSE

Antihistamine

USES

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

WARNINGS

Do Not Use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

ASK DOCTOR

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

WHEN USING THIS PRODUCT

  • drowsines may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinary.

STOP USE

Stop use and ask a doctor if an allergic reaction tothis product occurs. Seek medical help right away.

IF PREGNANT OR BREAST FEEDING:

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact Poison Control Center right away.

DIRECTIONS

Adults and children 6
 years and over 		one 10 mg tablet once daily, do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
Adults 65 years and overAsk a doctor
Children under 6 years of ageAsk a doctor
Consumers with liver or kidney diseaseAsk a doctor

OTHER INFORMATION

store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature]

INACTIVE INGREDIENTS

Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

QUESTIONS?

Call 1-844-874-7464

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Cetirizine Hydrochloride

GENERIC: Cetirizine Hydrochloride

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-0182-0

NDC: 70518-0182-1

NDC: 70518-0182-2

NDC: 70518-0182-3

NDC: 70518-0182-4

NDC: 70518-0182-5

NDC: 70518-0182-6

COLOR: white

SHAPE: BULLET

SCORE: No score

SIZE: 8 mm

IMPRINT: CTN;10

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 30 in 1 BOTTLE PLASTIC

PACKAGING: 100 in 1 BOTTLE PLASTIC

PACKAGING: 14 in 1 BOTTLE PLASTIC

PACKAGING: 5 in 1 BOTTLE PLASTIC

PACKAGING: 90 in 1 BOTTLE PLASTIC

PACKAGING: 7 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

  • Cetirizine Hydrochloride 10mg in 1

INACTIVE INGREDIENT(S):

  • hypromelloses
  • lactose
  • magnesium stearate
  • starch, corn
  • polyethylene glycol
  • povidone
  • titanium dioxide

MM2

MM5

MM6

MM7

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0182(NDC:16571-402)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorwhite (White) Scoreno score
ShapeBULLET (Barrel Shaped) Size8mm
FlavorImprint Code CTN;10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-0182-030 in 1 BLISTER PACK; Type 0: Not a Combination Product01/27/201702/02/2017
2NDC:70518-0182-130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/27/201710/13/2023
3NDC:70518-0182-2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/22/201705/04/2018
4NDC:70518-0182-314 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/201704/13/2017
5NDC:70518-0182-45 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/09/201710/13/2023
6NDC:70518-0182-590 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/09/201810/13/2023
7NDC:70518-0182-67 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/15/202310/13/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07782901/27/201710/13/2023
Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2023
Document Id: 079b8ca4-702b-6688-e063-6394a90aa63d
Set id: da2d7780-2c75-46f1-af2d-2d2bb371a993
Version: 19
Effective Time: 20231013
 
REMEDYREPACK INC.